Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services

Conditions

• Autism Spectrum Disorder
• Executive Functioning

Eligibility Criteria

Sex

ALL

Age

6 Years - 99 Years

Healthy Volunteers

Accepted

Interventions

• Unstuck and On Target — BEHAVIORAL
  Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.
• Unified Protocol for Children — BEHAVIORAL
  Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).

Study Details

This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.

Key Dates

Start date

Dec 15, 2024

Status verified

Apr 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

672 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Unstuck and On Target
  Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.
• Active Comparator: Unified Protocol for Children
  Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).

Primary Outcome Measure

Changes in Child Mental Health Symptoms [ Time Frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation ]

Central Contacts

• Kelsey S Dickson, PhD
  858-966-7703
  [email protected]
• Hannah E Reynolds, MPH
  [email protected]

Locations (2)

Find similar trials in San Diego, CA

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